Stage IIb/IIIa hepatocellular carcinoma
Conditions
Interventions
Group 1:Camrelizumab + Apatinib mesylate
Group 2:Camrelizumab+mXELOX
Sponsors
Cancer Hospital Affiliated to Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-70 years old, both male and female; 2. Patients with clinical stage IIb / IIIa; 3. Patients with HCC confirmed by histology or cytology have measurable tumor focus (spiral CT or MR scan >= 10 mm, meeting RECIST 1.1 standard); 4. Patients without extrahepatic metastasis; 5. Patients with child Pugh grade A or B; 6. Patients who have not received anti-tumor therapy for HCC before operation, including chemotherapy and local treatment; 7. ECoG PS: 0-1 points of patients; 8. Patients whose function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors during screening period): (1) The results showed that the absolute count of neutrophils >= 1.5 * 10^9 / L; platelets >= 100 * 10^9 / L; hemoglobin >= 9 g / dl; serum albumin >= 2.8 g / dl; (2) Thyroid stimulating hormone (TSH) <= 1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 times ULN, ALT and AST <= 5 times ULN; (4) Serum creatinine <= 1.5 times ULN. 9. Patients with an expected survival time of more than 3 months; 10. Patients with non-surgical sterilization or childbearing age women need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; the serum or urine HCG test of non-surgical sterilization women of childbearing age must be negative within 72 hours before the study enrollment; and they must be non lactating; for men, it should be surgical sterilization or agree to be in the trial During the test period and within 3 months after the last administration of the test drug, appropriate contraceptive methods were used; 11. The patients voluntarily joined the study and signed the informed consent form (ICF). They had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with complications that need to be treated, such as ascites or pleural effusion with clinical symptoms, need therapeutic puncture or drainage; or the unresected tumor has active bleeding; 2. Patients who have suffered from other malignant tumors before or at the same time are excluded from those who have received adequate treatment for non melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma; 3. Patients with active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA >= 10 copies / ml; hepatitis C: positive for HCV antibody and HCV-RNA, requiring antiviral treatment at the same time); 4. Patients with active tuberculosis infection. Patients with active tuberculosis infection within one year before medication should be excluded even if they have been treated; patients with active tuberculosis infection history more than one year should also be excluded, unless it is proved that they have received standard anti tuberculosis treatment before; 5. Patients with active, known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism who received hormone replacement therapy only and skin diseases (such as vitiligo, psoriasis or alopecia) without systemic treatment could be enrolled; 6. Patients with previous interstitial lung disease or (non infectious) pneumonia who need oral or intravenous steroid therapy; 7. Patients with poorly controlled heart disease, such as: (1) NYHA grade 2 and above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or ventricular arrhythmias with clinical significance and need treatment or intervention; 8. Patients with hypertension who cannot be well controlled by antihypertensive drugs (SBP >= 140 mmHg or DBP >= 90 mmHg); 9. Patients with abnormal coagulation function (PT > 16S, APTT > 43S, TT > 21s, FBG < 2G / L) had bleeding tendency or were receiving thrombolytic or anticoagulant therapy; 10. Patients with significant clinical bleeding symptoms or definite bleeding tendency within the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or vasculitis; 11. The subjects were known to have been allergic to macromolecular protein preparations or to any component of calicizumab; 12. Patients with active infection who need systemic treatment; 13. Patients with HIV, HIV 1 / 2 antibody positive; 14. Patients who have received or will be vaccinated with live vaccine within 30 days before the administration of carrizumab; 15. Patients with a history of psychotropic substance abuse, alcoholism or drug use; 16. Other factors that may affect the safety or compliance of the subjects as judged by the researcher. For example, serious diseases (including mental diseases), serious laboratory abnormalities, or other family or social factors that need to be treated together.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 removal rate;Objective response rate;Pathological complete response rate (pCR); | — |
Countries
China
Contacts
Public ContactYubao Zhang
Cancer Hospital Affiliated to Harbin Medical University
Outcome results
None listed